Cleared Special

K191083 - COMPLETE CONTROL System Gen2 (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191083 · Coapt, LLC · Neurology device
May 2019
Decision
30d
Days
Class 2
Risk

K191083 is an FDA 510(k) clearance for the COMPLETE CONTROL System Gen2. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Coapt, LLC (Chicago, US). The FDA issued a Cleared decision on May 24, 2019 after a review of 30 days — a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 — the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K191083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2019
Decision Date May 24, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 163d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K191083.
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